A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir in Participants with Moderate COVID-19 Compared to Standard of Care Treatment

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Study Overview

This study is for patients in the hospital being treated for COVID-19

There are no approved medications to treat COVID-19, a new disease caused by a virus called SARS-CoV-2 that was just identified in late 2019. Some people who become sick with COVID-19 develop a very serious disease. The purpose of this study is to see if Remdesivir (RDV) can improve your health from being sick with COVID-19 infection. The other purpose of this study is to test if RDV is safe and tolerated by people with moderate COVID-19. We will find out all these things, and also how long it stays in your body, using physical exams, laboratory tests, and any symptoms or problems you might experience during the study.

Study Description

This is a randomized, open-label study. 
 Randomized means the study treatment you take will be chosen by chance - like flipping a coin.  You will have a 1 out of 3 chance to get RDV for 5 days, 1 out of 3 chance to get RDV for 10 days and 1 out of 3 chance to not get RDV at all. Whatever happens you will still get standard of care treatment.
 
Open-label means you and your study doctor will know whether you get RDV and if you get it, for how long.
 
If you get RDV, you will get it by injections directly into the vein (intravenously, IV).
 
You cannot choose which study group you are in. If you agree to take part in this study and meet all the requirements, you will be randomized to one of the following study treatment groups:
 
Study Treatment Group 1 – You will get standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4 and 5.
 
Study Treatment Group 2 – You will get standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4, 5, 6, 7, 8, 9 and 10.
 
Study Treatment Group 3 – You will get standard of care treatment. You will not get any RDV.
 
If you get RDV, it may help treat your COVID-19. However, we do not know if this will happen. You may not get any benefit from taking part in this study.  Studies are a way for doctors to see if a drug is useful in treating a disease.
 
Taking part in this study may help us know more about how to treat people with SARS-CoV-2 infection. If you take part in this study, your health will be monitored closely.

  • Study Identifier: 842783

Recruitment Status

Enrolling By Invitation

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